Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance
- 1 November 2012
- journal article
- research article
- Published by Health Affairs (Project Hope) in Health Affairs
- Vol. 31 (11), 2518-2527
- https://doi.org/10.1377/hlthaff.2012.0104
Abstract
In response to the 2009 H1N1 pandemic and subsequent vaccination program, the Department of Health and Human Services and collaborators developed the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program as a demonstration project to detect rare adverse events rapidly. The program monitored three million people who had received the H1N1 vaccine by linking data from large private health plans and from public immunization registries that had originally not been designed to share data, and on a larger scale than had been previously attempted. The program generated safety data in two weeks rather than three to six monty 10ths—the standard time frame achievable using health plan data. PRISM substantially contributed to the understanding of the safety of H1N1 vaccines. Its use in the case of H1N1 highlights the necessity of proactive planning, scalable infrastructure, and public-private partnerships in tracking adverse events after vaccination in epidemics. It also illustrates how data could be integrated to produce policy-relevant information for other medical products.Keywords
This publication has 13 references indexed in Scilit:
- Surveillance for Guillain–Barré Syndrome After Influenza Vaccination Among the Medicare Population, 2009–2010American Journal of Public Health, 2012
- Surveillance for Adverse Events Following Receipt of Pandemic 2009 H1N1 Vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) System, 2009-2010American Journal of Epidemiology, 2012
- H1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink ProjectAmerican Journal of Preventive Medicine, 2011
- Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination ProgramPublished by American Academy of Pediatrics (AAP) ,2011
- Distributed Health Data NetworksMedical Care, 2010
- A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine StudyPharmacoepidemiology and Drug Safety, 2008
- Protecting Public Trust in ImmunizationPublished by American Academy of Pediatrics (AAP) ,2008
- Active Surveillance of Vaccine SafetyEpidemiology, 2005
- Safety considerations for new vaccine developmentPharmacoepidemiology and Drug Safety, 2001
- Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United StatesPediatrics, 1997